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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00340314 |
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Date of registration:
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19/06/2006 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Trial of Circumferential Pulmonary Vein Ablation (CPVA) Versus Antiarrhythmic Drug Therapy in for Paroxysmal Atrial Fibrillation (AF)
APAF2 |
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Scientific title:
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A Controlled Randomized Trial of Circumferential Pulmonary Vein Ablation Versus Antiarrhythmic Drug Therapy in Treating Paroxysmal Atrial Fibrillation. The Ablation for Paroxysmal Atrial Fibrillation (APAF2) Trial |
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Date of first enrolment:
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January 2005 |
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Target sample size:
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198 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00340314 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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Italy
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Contacts
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Name:
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Vincenzo Santinelli, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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San Raffaele University Hospital, Villa Maria Cecilia Hospital, Cotignola (Ravenna), Italy |
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Name:
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Carlo Pappone, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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San Raffaele University Hospital, Villa Maria Cecilia Hospital, Cotignola (Ravenna), Italy |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Age 18-70 years
2. History of symptomatic paroxysmal AF lasting more than 6 months. Paroxysms of AF are
intended as recurrent self-terminating episodes lasting less than 7 days and
occurring more than 2 times every month.
Exclusion Criteria:
1. Pregnancy
2. NYHA functional class III or IV
3. Left atrial size > 65 mm
4. Left ventricular (LV) ejection fraction < 35%
5. Contraindication to anticoagulation with warfarin
6. History of myocardial infarction within six months of the procedure
7. Prior catheter or surgical ablation attempt for AF
8. Inability or unwillingness to provide written informed consent
9. Life expectancy less than 1 year
10. Significant comorbid conditions such as: cancer (not cured), end stage renal disease
(creatinine clearance < 20 mL/h), severe chronic obstructive lung disease, cirrhosis,
etc)
11. Anticipated cardiac surgery for congenital, valvular, aortic or coronary heart
disease.
12. Presence of left atrial thrombus.
13. Prior antiarrhythmic drug therapy with amiodarone, sotalol and flecainide at optimal
doses (target 200 mg, 240 mg, 200 mg daily respectively
14. AF burden < 2 episodes/month
15. WPW
16. Expected survival < 1 year
17. Contraindications for antiarrhythmics therapy including flecainide, sotalol or
amiodarone not listed above:
- LV hypertrophy (LV mass index > 125g/m2)
- thyroid dysfunction (hyperthyroidism or uncontrolled hypothyroidism or thyroid
cancer)
- liver dysfunction (ALT or AST >2x the reference values)
- Interstitial lung disease with DLCO<70% of predicted or severe asthma.
- QT interval exceeding 400 msec
- Symptomatic sinus node or atrioventricular node dysfunction unless a pacemaker
had been implanted
- Evidence of stress-induced myocardial ischemia
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Atrial Fibrillation
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Intervention(s)
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Drug: Antiarrhythmic Drug Therapy
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Procedure: Circumferential Pulmonary Vein Ablation
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Primary Outcome(s)
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The primary end point was freedom from recurrent atrial tachyarrhythmias ([AT], both AF and regular atrial tachycardia) during a 12 and 48 months follow-up . The first analysis was scheduled to be performed after the last enrolled patient complete.
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Secondary Outcome(s)
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Percent of patients totally free of AF
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Efficacy and safety of two ablation catheters
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Presence of SR during 1-month intervals
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Incidence of cardiovascular hospitalization
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Procedure duration, length of hospital stay
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Overall morbidity
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Thromboembolic and bleeding complications
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LV function
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Number of cardioversions
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Efficacy and safety of two 3D mapping systems
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Left atrial size and function
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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